Regulatory Trials Specialist II — Remote/Hybrid

Stanford University; Palo Alto (CA); Hybrid; USD 110,000 - 165,000; Full time

Job summary

Stanford University’s Clinical Research Hub (CRH) seeks a mission-driven Regulatory Specialist 2 to ensure GCP and SOP compliance across clinical trials. You will collaborate with clinical operations, QA, education, finance, and business development teams, and engage sponsors, IRBs, FDA, and other regulators.

The ideal candidate has experience in regulatory submissions, strong communication and diplomacy, and the ability to manage multiple projects.

Qualifications

• Experience with regulatory submissions to regulators (IRB, FDA, etc.).
• Strong knowledge of GCP and SOP frameworks.
• Proven ability to manage multiple clinical trials concurrently.

Responsibilities

• Ensure compliance with GCP and SOPs across trials.
• Collaborate with clinical operations, QA, education, finance, and BD managers.
• Engage with sponsors, clinical researchers, IRBs, FDA, and other authorities.
• Lead or support regulatory submissions and lifecycle activities.

Skills

Regulatory submissions

GCP compliance

SOP adherence

Stakeholder collaboration

Project management

Interpersonal communication

Diplomacy

Multi-project coordination

Job description

Stanford University’s Clinical Research Hub (CRH) seeks a mission-driven Regulatory Specialist 2 to ensure GCP and SOP compliance across clinical trials. You will collaborate with clinical operations, QA, education, finance, and business development teams, and engage sponsors, IRBs, FDA, and other regulators.

The ideal candidate has experience in regulatory submissions, strong communication and diplomacy, and the ability to manage multiple projects.